COSMIC: Chemotherapy plus Ofatumumab at Standard or Mega dose In C

• Conditions: Chronic Lymphocytic Leukaemia (CLL); MedDRA version: 17.0Level: PTClassification code 10008958Term: Chronic lymphocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-000796-14-GB
• Lead Sponsor: eeds Teaching Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-17
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

Patients fulfilling all of the following criteria are eligible for the study:

-At least 18 years old
-Chronic lymphocytic leukaemia requiring therapy
-Previous treatment with at least one chemotherapeutic regime
-Be capable of giving written informed consent
-World Health Organisation (WHO) performance status (PS) of 0, 1, or 2
-Life expectancy of at least 12 weeks
-Considered fit enough to receive fludarabine-based or bendamustine-based combinations

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Patients with any of the following characteristics are ineligible for the trial:
-Applies only to participants to receive FC: Fludarabine refractory - defined as no response to or relapse within 6 months of fludarabine alone or in combination with cyclophosphamide (FC).
-Applies only to participants to receive FC: Relapse within 12 months of FC with rituximab (FCR).
-Applies only to participants to receive B: Bendamustine refractory (defined as no response to or relapse within 6 months of bendamustine alone or in any combinations other than with rituximab).
-Applies only to participants to receive B: Relapse within 12 months of bendamustine in combination with rituximab.
-Deletion of chromosome 17p on FISH
-Previous treatment with ofatumumab either alone or in combination with chemotherapy.
-Patients who previously experienced toxicity attributable to fludarabine or bendamustine such as autoimmune haemolytic anaemia, neurological toxicity or allergy should not be exposed to the same drug (if considered appropriate patients experiencing toxicity to fludarabine can be treated with bendamustine and vice versa).
-Active infection.
-Other severe, concurrent (particularly cardiac or pulmonary) diseases or mental disorders that could interfere with their ability to participate in the study.
-Patients with a creatinine clearance of less than 30ml/min should not be given fludarabine.
-Patients with a creatinine clearance of less than 10ml/min should not be given fludarabine or bendamustine.
-Pregnant, lactating or women of child bearing potential unwilling to use medically approved contraception whilst receiving treatment and for 12 months after treatment has finished.
-Men whose partners are capable of having children but who are not willing to use appropriate medically approved contraception whilst receiving treatment and for 12 months after treatment has finished, unless they are surgically sterile. (Men who will be treated with bendamustine should seek advice about sperm conservation prior to treatment because of possible irreversible infertility)
Participants meeting any of the following criteria must not be enrolled in an ofatumumab study:
-Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
-Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study
-Other past or current malignancy. Subjects who have been free of malignancy for at least 2 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
-Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapy.
-Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C.
-History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
-Known HIV positive
-Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart fa

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified